U.S. patent number 7,785,340 [Application Number 10/066,994] was granted by the patent office on 2010-08-31 for bonding sleeve for medical device.
This patent grant is currently assigned to Boston Scientific Scimed, Inc.. Invention is credited to Matthew C. Heidner, Thomas J. Holman.
United States Patent |
7,785,340 |
Heidner , et al. |
August 31, 2010 |
Bonding sleeve for medical device
Abstract
A medical device delivery system comprises an inner tube, a
medical device disposed about a portion of the distal region of the
inner tube, a medical device sheath disposed about the medical
device, a medical device sheath retraction device extending
proximally from the medical device sheath and an outer sheath
disposed about a portion of the medical device sheath retraction
device. The distal end of the outer sheath terminates at least one
medical device length proximal of the medical device. The medical
device sheath is movable relative to the outer sheath and relative
to the inner tube.
Inventors: |
Heidner; Matthew C. (Maple
Grove, MN), Holman; Thomas J. (Minneapolis, MN) |
Assignee: |
Boston Scientific Scimed, Inc.
(Maple Grove, MN)
|
Family
ID: |
27658780 |
Appl.
No.: |
10/066,994 |
Filed: |
February 4, 2002 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20030149465 A1 |
Aug 7, 2003 |
|
Current U.S.
Class: |
606/194; 606/108;
623/1.11 |
Current CPC
Class: |
A61F
2/958 (20130101); A61F 2002/9583 (20130101) |
Current International
Class: |
A61M
29/00 (20060101); A61F 2/06 (20060101) |
Field of
Search: |
;606/194,108 ;623/1.11
;604/103.01,509,524,529 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
US. Appl. No. 09/684,255, filed Oct. 6, 2000, Justin Eric Plessel.
cited by other.
|
Primary Examiner: Bui; Vy Q
Attorney, Agent or Firm: Vidas, Arrett & Steinkraus,
P.A.
Claims
What is claimed is:
1. A catheter comprising: a distal shaft having a length, a
substantially constant outer diameter along a majority of its
length, a lumen and a proximal end; a proximal shaft having a
length, a substantially constant outer diameter along a majority of
its length, a wall defining an inner lumen and a distal end, the
distal end of the proximal shaft being connected to the proximal
end of the distal shaft and the lumens of the respective shafts
being in fluid communication with one another; a heat shrinkable
sleeve having a longitudinal length extending from a proximal-most
end to a distal-most end of said heat shrinkable sleeve, and
overlapping the proximal end of the distal shaft and the distal end
of the proximal shaft providing a water seal, wherein said
longitudinal length consists of a small portion of the distal end
of the proximal shaft and a small portion of the proximal end of
the distal shaft; and a port, wherein the port is positioned
between the first and second ends of the heat shrinkable sleeve and
formed at least partially transversely through the wall of the
proximal shaft, wherein the catheter is sterilized and prepared to
safely enter a body.
2. The catheter of claim 1, wherein the distal shaft and the
proximal shaft overlap.
3. The catheter of claim 1, wherein the heat shrinkable sleeve
comprises a thermoplastic polymer which is substantially not
cross-linked.
4. The catheter of claim 1, the heat shrinkable sleeve being
gradually heat shrunk along its length around the distal shaft and
proximal shaft.
5. The catheter of claim 1, wherein the retaining sleeve is formed
from a material chosen from the group consisting of a liquid film,
wherein the film solidifies prior to the bonding of the balloon to
the shafts or a gel, wherein the gel hardens prior to the bonding
of the balloon to the shafts.
6. The catheter of claim 1, wherein the proximal shaft is
metal.
7. The catheter of claim 1, further comprising an inner shaft
within the distal shaft, wherein the inner shaft is in
communication with the port.
8. The catheter of claim 1, wherein the port is formed in the
proximal shaft.
9. The catheter of claim 1, wherein the port is at least partially
formed in the distal shaft.
10. The catheter of claim 1, wherein the port is formed in the
distal shaft and the proximal shaft.
11. The catheter of claim 1, wherein the distal shaft and the
proximal shaft abut each other.
12. The catheter of claim 7, wherein the inner shaft is a guide
wire shaft, through which a guide wire may be used.
Description
FIELD OF THE INTENTION
This invention relates to catheters used for multiple procedures,
including for delivering medical devices, such as stents, and a
method of making the catheter systems. The delivery system employs
a sleeve which aids in the bonding of parts of the catheter and is
capable of becoming a part of the final system product.
BACKGROUND OF THE INVENTION
Catheters are used for many medical purposes. The present invention
is not limited to a specific type of catheter, rather a method of
making the catheter and the resulting product. Examples of
catheters and procedures are addressed below for the sake of
background.
In typical PTA or PTCA procedures, a guiding catheter is
percutaneously introduced into the cardiovascular system of a
patient and advanced through the aorta until the distal end is in
the desired (coronary) artery. Using fluoroscopy, a guide wire is
then advanced through the guiding catheter and across the site to
be treated in the coronary artery. An over the wire (OTW) balloon
catheter is advanced over the guide wire to the treatment site. The
balloon is then expanded to reopen the artery. The OTW catheter may
have a guide wire lumen which is as long as the catheter or it may
be a rapid exchange catheter wherein the guide wire lumen is
substantially shorter than the catheter. Alternatively, a fixed
wire balloon may be used. This device features a guide wire which
is affixed to the catheter and cannot be removed.
To help prevent arterial closure, repair dissection, or prevent
restenosis, a physician can implant an intravascular prosthesis, or
a stent, for maintaining vascular patency inside an artery or other
vessel at the lesion.
Stents are also used for a variety of other purposes including
maintaining the patency of any physiological conduit including
arteries, veins, vessels, the biliary tree, the urinary tract, the
alimentary tract, the tracheobronchial tree, the genitourinary
system, and the cerebral aqueduct.
The stent may either be self-expanding or balloon expandable. For
the latter type, the stent is often delivered on a balloon and the
balloon is used to expand the stent. The self-expanding stents may
be made of shape memory materials such as nitinol or constructed of
regular metals but of a design which exhibits self expansion
characteristics.
The present invention is directed to the area of constructing
catheters and other medical devices such as described above. Each
catheter has many parts which must be interconnected with high
accuracy and precision. Typically parts are adhered or thermally
bonded together. Using retaining sleeves as an example (examples of
which may be found in U.S. Pat. No. 4,950,227, U.S. Pat. No.
6,221,097, U.S. Pat. No. 6,068,634, U.S. Pat. No. 5,980,530, U.S.
Pat. No. 5,968,069 and U.S. Pat. No. 5,044,726), welding may be
accomplished by heating the retaining sleeve or by applying laser
radiation to the retaining sleeve at a wavelength absorbed by the
retaining sleeve. CO.sub.2 lasers have proven to be particularly
useful in this regard. Adhering and Welding methods are well known
in the industry. An example of the use of laser welding may be
found in U.S. application Ser. No. 09/684,255.
All U.S. patents and applications all other published documents
mentioned anywhere in this application are incorporated herein by
reference in their entirety.
Without limiting the scope of the invention in any way, the
invention is briefly summarized in some of its aspects below.
SUMMARY OF THE INVENTION
The present invention is directed to using a sleeve to hold parts
and joints of a catheter together such that they may be bonded
together, wherein the sleeve remains on the catheter after the
bonding to form parts of the final catheter product. With thermal
bond welding, the sleeve is aligned and heat shrunk on the catheter
to constrain the individual parts of the medical device, after
which they are bonded in place. Instead of removing the sleeve, it
remains to form part of the medical device. The sleeve which
remains may form a useful part or a non-useful part which does not
adversely affect the use of the medical device. As will be
discussed below, the sleeve may vary in length along the catheter,
providing for various final parts. In typical embodiments the
sleeve, or at least a portion of the sleeve, is considered to be
non-removable.
Initially, the sleeve is positioned over and around the catheter
parts to be bonded together or to be encapsulated. A heating unit
is used to apply heat to the sleeve to shrink it on the catheter.
Heat, or any other method used to shrink the sleeve, is applied to
one spot and then gradually moved along the length of the sleeve,
gradually removing air and space between the sleeve and the
catheter parts. The parts of a catheter then are bonded together
via known techniques, such as adhesion, thermal welding, RF welding
and ultrasonic welding. Portions, or all, of the sleeve are welded
onto the catheter as well. After the bonding is complete the sleeve
of the present invention remains in place providing an additional
part, such as stent retaining sleeves, a distal tip or a protective
cover. This eliminates the step of removing the holding sleeve in
the normal process, saving time and finances.
The invention also contemplates certain coatings, pastes, gels or
films may also be employed to constrain and/or form parts during
bonding and become a part of the finished bonded component.
The invention is not limited to catheters. It may be applied to
other medical items which use sleeves of the like to hold parts of
the medical items together in order to bond them. Catheters are
only used in the description for examples purposes.
The disclosure below involves simplifying the process of bonding
construction as well as providing new methods of forming required
parts of medical devices.
BRIEF DESCRIPTION OF THE FIGURES
FIG. 1 is a cross-sectional view of the distal end of a catheter
illustrating a particular embodiment of the invention;
FIG. 2 is a cross-sectional view of the distal end of a catheter
illustrating a further embodiment of the invention;
FIG. 3 is a cross-sectional view of the distal end of a catheter
illustrating a further embodiment of the invention;
FIG. 4 is a cross-sectional view of the embodiment shown in FIG. 3,
having the balloon in expanded form;
FIG. 5 is a cross-section view of the embodiment of FIG. 1, wherein
the sleeve is being heat shrunk onto the catheter;
FIG. 6 is a cross-section view of a catheter mid-shaft to be
bonded;
FIG. 7 is a cross-section view of a portion of a rapid exchange
catheter illustrating a further embodiment;
FIG. 8 is an exploded cross-section view of a portion of a rapid
exchange catheter illustrating a further embodiment;
FIG. 9 is an exploded cross-section view of a portion of a rapid
exchange catheter illustrating a further embodiment;
FIG. 10 is an exploded cross-section view of a portion of a rapid
exchange catheter illustrating a further embodiment;
FIG. 11 is a cross-sectional view of the distal end of a catheter
illustrating a further embodiment of the invention; and
FIG. 12 is a cross-sectional view of the distal end of a catheter
illustrating a further embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
While this invention may be embodied in many different forms, there
are shown in the drawings and described in detail herein specific
embodiments of the invention. The present disclosure is an
exemplification of the principles of the invention and is not
intended to limit the invention to the particular embodiments
illustrated.
For the purposes of this disclosure, the term stent refers to
stents, stent-grafts, grafts and other endoluminal prostheses
whether self-expanding, balloon expandable, self-expanding and
balloon expandable or otherwise expandable as are known in the
art.
In addition to the over-the-wire embodiments (example also found in
U.S. Pat. No. 5,980,533) shown in the figures, the inventive
catheter system and methods may also be provided in any catheter
system, such as plain balloon angioplasty catheters and
rapid-exchange configurations. Examples of rapid-exchange catheters
may be found in U.S. Pat. No. 5,534,007 and U.S. Pat. No.
5,833,706. The inventive stent delivery systems may also be made in
fixed wire form. Examples of fixed-wire catheters may be found in
U.S. Pat. No. 5,702,364.
The system may be adapted for use with a medical device such as a
stent, for example, a self-expanding, balloon expandable or
combination self-expanding and balloon expandable stent. The system
may also be used for delivery of other medical devices for use in
the body as well including, but not limited to, ultrasonic devices,
laser devices, vena cava filters, drug coated sleeves and other
implantable drug delivery devices and the like.
The inventive medical systems disclosed herein may also be provided
with any of the features disclosed in U.S. Pat. No. 6,096,056, U.S.
Pat. No. 6,068,634, U.S. Pat. No. 6,036,697, U.S. Pat. No.
6,007,543, U.S. Pat. No. 5,968,069, U.S. Pat. No. 5,957,930, U.S.
Pat. No. 5,944,726, U.S. Pat. No. 5,653,691 and U.S. Pat. No.
5,534,007.
The stent delivery system may also comprise various coatings as are
known in the art, including lubricious coatings to facilitate
movement of the various parts of the system, as well as
collagen-type coatings. More information concerning suitable
coatings may be found in U.S. Pat. No. 5,443,907, and U.S.
application Ser. Nos. 08/382,478, 09/306,939 and 09/316,502.
The invention is also directed to medical device delivery systems
and catheters produced using the inventive methods.
For the purposes of the detailed description of the invention,
figures of a portion of the distal end of a typical balloon
catheter will be used. It should be understood, as mentioned above,
that the present invention is applicable to other portions of the
catheter as well as other medical devices, which use a constraining
sleeve for bonding parts and joints together. It should also be
understood that the materials used may be any of those materials
known in the art where applicable.
For the purposes of this disclosure, unless otherwise indicated,
identical reference numerals used in different figures refer to the
same component.
FIG. 1 illustrates the distal end of a typical balloon catheter 10
for delivering stent to a specific location within the body. The
catheter 10 has an outer sheath 12 which extends over the body of
the catheter 10. The catheter also comprises an inner shaft 14
forming an inner lumen 18, which allows access for a guide wire 15.
A balloon 16 is mounted on the catheter 10 at the distal end. The
proximal end of the balloon 20, in this type of catheter, is bonded
to the distal end 22 of the outer sheath 12 at point 24. In other
embodiments, the proximal end of the balloon may also be bonded to
the inner shaft. The catheter is typically guided through a guide
catheter 53 (shown in FIG. 4).
The distal end of the balloon 26 is mounted on the inner shaft 14
and will eventually be bonded to the inner shaft 14 at point 28.
There is a distal tip 30 at the distal end of the catheter, but, as
will be explained later, it may not be needed due to the forming of
a distal tip by the sleeve 32 (hereafter called sleeve 32). Marker
bands 31 are also illustrated.
The sleeves of the present embodiments suitably comprise non-cross
linked thermoplastics, such as olefins and tecothanes, so that
bonding and flowing is enhanced.
The parts of the catheter to be made are held together via the
sleeve 32. As mentioned above, the sleeve 32 is heat shrunk around
the parts to be permanently bonded to constrain them in place as a
bonding aid. This is done typically at 200-250.degree. F., however,
the material dictates the temperature. In this instance, as shown
in FIG. 5, a heating element 41, such as a heat gun, a hot block or
hot jaws, is used to apply heat to a point 43 on sleeve 32. The
heating element can be applied directly on the surface of the
sleeve 32. The heating element 41 can be then moved along the
length of the sleeve 32, as shown, causing the sleeve 32 material
to shrink, and optionally flow. Depending on the type of heating
element used, movement may not be needed. The temperature is
dictated by the material used. The heat must be sufficient to
shrink the sleeve, but not so hot as to break the material down so
as to destroy the integrity of the sleeve. By heating the material
at or slightly above its melt temperature, the material will flow
and create a fuse bond where bonds are desired.
This bonding may be dictated by the part which is being made. For
example, in the case of forming a stent retaining sleeve, it may be
desirable to only bond a part of the sleeve, leaving the remaining
portion shrunk but not bonded. This allows the stent retaining
sleeve to be capable of moving relative to the balloon for
effective release of the stent during delivery. Complete bonding of
the parts together at desired spots can be completed during the
welding procedures.
The moving heating element seals the sleeve 32 to the catheter,
holding the parts of the catheter together. The longitudinal moving
of the heating element and the flow of the sleeve 32 material
stretches the material out and removes any air pockets to result in
a tight, uniform fit. The shrinking of the sleeve 32 can start at
one end of the sleeve 32, proceeding to the opposite end. However,
it is contemplated that the shrink may start at any place along the
sleeve, gradually moving longitudinally.
The bonding of the parts of the catheter is then started, suitably
done by laser welding. The sleeve remains as part of the final
product and in some cases can be used to hold a loaded stent in
place during sterilization. In FIG. 1, sleeve 32 remains to form
the distal tip of the catheter. In all cases, the sleeve may also
act as an added protective layer and be lubricated for easy
movement through body lumens.
The port 34 of the inner lumen 18 may be closed due to the heat
shrunk sleeve 32 until needed. If the catheter were a back loaded
catheter, as shown, the guide wire 15 would pierce the closed port
when needed.
A sleeve 55 may also be used to secure the marker bands 31 to the
inner shaft 14 during the securement of the marker bands 31 to the
shaft 14. Sleeve 55 remains a part of the catheter and may be a
soft protective cover over the marker band 31 to protect the
balloon 16 from being damaged by the marker bands 31. Sleeve 5 may
be used in any of the embodiments.
In the embodiment shown in FIG. 2, a larger sleeve 36 is used. The
word larger is used in terms of length of coverage over the
catheter. In addition to the functions of sleeve 32, as described
above, sleeve 36 also forms a distal stent retaining sleeve 38. As
mentioned above, stent retaining sleeves are known. The materials
and methods for applying and using the sleeve 32 are similarly
applicable here. Retaining sleeve 38 can aid in holding the stent
40 in place.
The invention also contemplates a sleeve which may extend up the
cones of the balloon, but not over the end of the stent. Such a
sleeve may aid in balloon rewrap as well as provide leading
lubrication for the catheter to aid in trackability of the
stent.
The use of retaining sleeves to retain a stent on a catheter has
been disclosed in a number of patents including U.S. Pat. No.
4,950,227 to Savin et al., U.S. Pat. No. 5,403,341 to Solar and
U.S. Pat. No. 5,108,416 to Ryan et al., as well as U.S. Pat. No.
5,944,726 and U.S. Pat. No. 5,968,069. One or more retaining
sleeves typically retain the stent on the catheter when the stent
is in an unexpanded state. Upon expansion of the stent, the
retaining sleeves release the stent.
FIG. 3 illustrates another embodiment. The method of applying the
stent is the same. In this embodiment, an even larger sleeve 42 is
used. In addition to the function of sleeves 32 and 36, as
described above, sleeve 42 also forms a proximal stent retaining
sleeve 44 which extend down the proximal end of the balloon 16,
over the balloon waist 20. It should be understood that, the sleeve
42 may extend further in the proximal direction to provide for
bonding at point 24. In this embodiment, sleeve 42 covers the
entire balloon section, as well as the stent 40.
As described above, sleeve 42 constrains the parts of the catheter
in this area until they are fully bonded, such as through laser
welding. As with the other sleeves, sleeve 42 remains in place for
sterilization and use. As part of the final catheter, sleeve 42
forms a distal tip 46, a distal stent retaining sleeve 48 and a
proximal stent retaining sleeve 44. Sleeve 42 also forms a tubular
member 50 which surrounds the stent. This member may be used in the
final product or discarded, according to the application. To allow
the stent to eventually be separated from the catheter the stent
retaining sleeves 44, 48 are separated from the tubular member 50
by tear away perforations 52. The tubular member 50 also may be
drug eluting. It should be understood that an embodiment may
comprise a catheter wherein the heat shrinkable sleeve covers the
stent, but only provides one stent retaining portion, and therefore
only one circumferential perforation.
FIG. 4 shows the embodiment of FIG. 3 wherein the guide catheter 53
is withdrawn and the balloon 16 is expanded. As can be seen, the
retaining sleeves 44, 48 tear away, or are peeled, from the tubular
member 50 and fall away from the stent 40. The tubular member 50
must be made from a material which can expand with the stent.
If the tubular member 50 is meant to be left in the body, it
preferably should be biocompatible. In such a case, the stent
effectively pushes it into the artery wall. Biocompatible materials
are well known in the art. They include, but are not limited to
TEFLON and urethanes. The material may further include
pharmaceutical agents to prevent restenosis. Such agents may
comprise proteins with small molecules, such as taxol-containing
drugs, nucleotides and actinomycine. Materials which eventually
dissolves or disintegrates may also be used, such as polylactic
acid. The tubular material 50 may also incorporated drugs which aid
in the healing and acceptance of the stent, such as
anti-thrombogenic agents. These types of agents are well known.
Teflon or a flouropolymer may also be used for the tubular member
50 to protect against hyperplasia or restenosis. The member
prevents the vessels from growing back in on the delivered
stent.
The present invention contemplates a multi-material sleeve 42,
which is preassembled. In such a sleeve, the retaining sleeve
portions 44, 48 may be made of a material which has less elasticity
than the tubular member. The sleeve 42 may vary in other
characteristics as well, such as lubricity and strength.
It should be understood that the invention contemplates the use of
the sleeve in any welding application. FIG. 6 shows the process of
a catheter midshaft bonding between a proximal shaft 64 and a
distal shaft 62. Shaft 64 may be a metal hypotube. The ends of the
shafts are fitted onto a mandrel 68 for support. In accordance with
examples of the methods, a support mandrel may be used as support
for other parts to be bonded together. A sleeve 66 is shrunk around
the junction to be bonded. The sleeve 66 is then bonded to shafts
64, 62, providing a tight connection. The sleeve allows for a
connection which does not require that the shafts overlap, as seen
in FIG. 1 at 24, and thus a smooth inner transition. It should be
understood that the connection at 24 may also be created by this
method.
FIGS. 7-10 illustrate the use of a sleeve 84 in connecting and
sealing between a mid-shaft 72, a distal shaft 74 and a distal
inner shaft 76, which functions as a guide wire lumen, in a rapid
exchange catheter. Rapid exchange catheters are well known in the
art. These catheters are generally characterized in that a port 78
allows for insertion of certain parts from the outside of the
catheter to the inside anywhere along the length of the catheter.
In typical rapid exchange catheters, the port is for insertion of a
guide wire or an inflation lumen. Only the portion showing the port
78 and connection between the mid-shaft 72, distal shaft 74 and
distal inner shaft 76 is shown.
FIG. 7 shows the distal end 82 of the mid-shaft 72 inserted into
the proximal end 80 of the distal shaft 74. It should be understood
that the distal shaft 74 could be inserted into the midshaft 72 in
an inverted manner. A port 78 is positioned in the wall of the
distal shaft 74 and/or the wall of the midshaft, depending on the
port's positioning. In this particular embodiment, the port 78
opens into a guide wire lumen 76, which is bonded to the distal
shaft 74 and extends distally to the end of the catheter. A sleeve
84 is shrunk around the juncture of the shafts 72, 74. The shafts
are then bonded together.
The sleeve 84 also allows for a connection between the shafts 72,
74 with a smooth internal transition, as shown in FIGS. 8-10. In
these embodiments, as with the embodiment shown in FIG. 6, the ends
82, 80 of the shafts 72, 74 are adjacent, but not overlapping. The
shrunken sleeve 84 is used to connect the shafts 72, 74. The shafts
72, 74 need not be bonded directly to each other. Instead, the
sleeve 84 may be bonded to each shaft.
FIGS. 8-10 also show various positions of the port 78. FIG. 8 shows
the port 78 in the proximal end 80 of the distal shaft 74, FIG. 9
shows the port 78 in the distal end of the midshaft and FIG. 10
shows the port 78 being formed in the ends 80, 82 of both shafts
74, 72.
FIG. 11 illustrates a further embodiment of the invention. This
particular embodiment comprises a balloon 16 attached to the
catheter, a proximal stent retaining sleeve 44 and a distal stent
retaining sleeve 42, an outer sheath 12, a stent 40 and a proximal
shrunken sleeve 100 and a distal shrunken sleeve 102.
The invention contemplates incorporating the proximal sleeve 100 or
the distal sleeve 102 or both. As can be seen, the balloon is
positioned on the catheter and then the stent retaining sleeves
108, 110 are positioned. The stent retaining sleeves may extend
beyond the ends of the balloon, as shown with sleeve 110, to the
ends of the balloon, as shown with sleeve 108, or they may stop
short of the ends of the balloons. It should be understood that the
ends of the balloon 104 and the outer sheath 22 may overlap in
either manner. Only the manner in which the balloon end overlaps
the sheath end is shown.
In this particular embodiment, the shrunken sleeves 100, 102 are
shrunk down over these junctures. The bonds are then welded into
place and the sleeves 100, 102 are left in place. Arrows 111, 112
illustrate the preferred direction in which the sleeves 100, 102
are welded.
FIG. 12 illustrates an alternative juncture configuration between
the stent retaining sleeve, the balloon and the outer sheath. In
this particular configuration, end of the balloon 104 does not
overlap the end 22 of the outer sheath 12. The stent retaining
sleeve 108 extends beyond the end of the balloon and over or under
the end of the outer sheath. The shrunken sleeve 100 is then shrunk
down over the juncture and the components are then welded, as
discussed above.
For the examples shown, the medical balloon may be made of any
suitable material including Pebax.RTM.. Other suitable materials
are disclosed in U.S. Pat. No. 6,024,752, and U.S. Pat. No.
6,036,697.
For the examples shown, suitable materials for the outer
sheath/shaft are well known in the art and include high density
polyethylene (HDPE) and SURLYN.RTM. and those materials disclosed
in U.S. Pat. No. 6,036,697 and U.S. Pat. No. 5,543,007.
The effectiveness of the bonding may be limited by the
compatibility of the adjacent materials. Adjacent materials which
provide covalent bonding or molecular entanglement are examples of
suitable material.
For the examples shown, the inner shaft may be made of a flexible
construction having any collapse strength. The inner shaft may also
be made of an incompressible construction, such as a polymer
encapsulated braid or coil. The flexibility of the braid/coil
allows the medical device delivery system to navigate through body
lumens and the incompressibility of the braid/coil aids in
maintaining the integrity of the system and aids in deployment
accuracy when during release of the medical device. The braid/coil
may be comprised of stainless steel or nitinol, but desirably
stainless steel encased in a polymer such as a polyimide, HDPE,
Teflon or urethane, but desirably polyimide or Teflon. Other
suitable materials which may be used are well known in the art.
Portions of the sleeves may be radio opaque for the user to track
the positioning within the body. Methods of making the sleeve
material radio opaque are well known. Suitable examples include
doping the raw material with radio opaque materials.
The above sleeves also provide strain relief on joint of the
catheter by diffusing the strain placed upon the catheter during
storage and use.
Portions of the sleeves may be removed while other portions are
maintained as part of the final catheter when desired.
The sleeve may also take the form of a film/coating, paste or gel.
Typically, this embodiment may be used in parts of catheters which
are not subject to a significant degree of contraction or pressure,
such as a distal tip. A spray producing a dried film can be used,
providing adequate axial resistance for welding purposes. Suitable
materials include urethanes, polystyrenes and polyesters. For
pastes or gels, suitable ground up micro particles are dissolved
and applied to the medical device where needed. Axial resistance is
provided with time drying or via a catalyst.
The medical device delivery systems may be subjected to additional
processing steps prior to and/or subsequent to disposing the
retaining sleeve about the stent and balloon. For example, bumpers
and/or marker bands may be disposed about the inner tube or other
portions of the medical device delivery system. A retractable
sheath may be provided over the balloon and stent. A manifold may
also be provided at the proximal end of the medical device delivery
system. Other additional steps include providing to the inventive
medical device delivery devices any of the features disclosed in
U.S. Pat. No. 6,096,056, U.S. Pat. No. 6,007,543, U.S. Pat. No.
5,968,069, U.S. Pat. No. 5,957,930, U.S. Pat. No. 5,944,726 and
U.S. Pat. No. 5,653,691.
In addition to being directed to the embodiments described above
and claimed below, the present invention is further directed to
embodiments having different combinations of the dependent features
described above and/or claimed below.
Every patent, application or publication mentioned above is herein
incorporated by reference.
The above examples and disclosure are intended to be illustrative
and not exhaustive. These examples and description will suggest
many variations and alternatives to one of ordinary skill in this
art. All these alternatives and variations are intended to be
included within the scope of the claims, where the term
"comprising" means "including, but not limited to". Those familiar
with the art may recognize other equivalents to the specific
embodiments described herein which equivalents are also intended to
be encompassed by the claims. Further, the particular features
presented in the dependent claims can be combined with each other
in other manners within the scope of the invention such that the
invention should be recognized as also specifically directed to
other embodiments having any other possible combination of the
features of the dependent claims. For instance, for purposes of
claim publication, any dependent claim which follows should be
taken as alternatively written in a multiple dependent form from
all prior claims which possess all antecedents referenced in such
dependent claim if such multiple dependent format is an accepted
format within the jurisdiction (e.g. each claim depending directly
from claim 1 should be alternatively taken as depending from all
previous claims). In jurisdictions where multiple dependent claim
formats are restricted, the following dependent claims should each
be also taken as alternatively written in each single dependent
claim format which creates a dependency from a prior
antecedent-possessing claim other than the specific claim listed in
such dependent claim below (e.g. claim 6 may be taken as
alternatively dependent from any of claims 2-5, claim 4 may be
taken as alternatively dependent from claim 3; etc.).
* * * * *